Breast Implants - FDA Approves Allergan's New Silicone Gel-Filled Implant

The U.S. Food and Drug Administration approved a new silicone gel-filled breast implant, developed by Allergan Inc..

The new implants are meant to increase breast size in women who are at least 22-years-old and reconstruction in women of any age, according to the government agency's press release.

But Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health warns of the general risk associated with breast augmentation and reconstruction procedures.

"It's important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation of reconstruction surgery, and they should recognize that long-term monitoring is essential," he said in the press statement.

Allergan still requires post-approval studies to determine whether there are any long-term risks associated with the new implants.

"The data we reviewed showed a reasonable assurance of safety and effectiveness," Shuren said. "We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness."

The FDA's approval of the implant known as Natrelle 410 comes after seven years of analyzing data from 941 women.

And the government agency reports that the complications that were observed are consistent with previous breast implant studies and include tightening of the area around the implant, re-operation, implant removal, an uneven appearance and infection.

But researchers observed a unique complication associated only with the Natrelle 410 -- gel fractures.

The FDA reports that the Natrelle 410 implant is firmer in comparison to the company's predecessor Natrelle implant.

However, the approved implants can not be compared to any other FDA-approved implant on the market because the agency did not compare safety and effectiveness of the Natrelle 410 to another other silicone gel-filled breast implants.

Including the approval of the Natrelle 410, there are now four FDA-approved silicone gel-filled breast implants that are manufactured in the U.S. by three different companies: Allergan, Mentor and Sientra.

(SOURCE)